MyopiaNCT06411717
A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
A study testing Microstructure lens A and Microstructure lens B in people with Myopia, run by Suzhou Care-Real Medical Technology Co., Ltd. at 1 site in China.
Trial summary
The objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents. A total of 156 subjects meeting the requirements of the study protocol were included. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Myopia
- What is being tested?
- Microstructure lens A and Microstructure lens B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2024to 7 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must meet all criteria to be enrolled in the study at the screening visit:
- Age 8~13 years old (including boundary values), gender is not limited;
- The spherical degree of subjective optometry in both eyes with cycloplegic muscle paralysis was between -1.00D and -6.00D (including the boundary value) (based on the mean value of subjective optometry), and the equivalent spherical difference of both eyes was less than 1.50D;
- Optimal corrected visual acuity ≥1.0 in left and right eye after ciliary muscle paralysis;
- In both eyes with cycloplegia, the degree of the column lens was ≤1.50 days;
- Voluntarily participate in the clinical study, sign the informed consent, and obtain the written consent of the guardian;
Who cannot join
- Subjects who met any of the following criteria at the time of the screening visit were excluded from the study:
- Have a history of eye trauma or intraocular surgery;
- Abnormal results of slit-lamp examination (see Annex 1 for details);
- fundus examination results ≥ grade 2 (see Annex 1 for details);
- Intraocular pressure < 10mmHg or > 21mmHg or intraocular pressure difference ≥5mmHg;
- Patients with other eye diseases, such as uveitis and other inflammation, glaucoma, cataract, fundus disease, eye tumors, eye trauma, dominant strabismus, and any eye lesions affecting visual function;
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- Associated diseases that may affect the eye (such as acute and chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, etc.);
- suffering from a mental disorder or other disease that the researcher deems unsuitable for wearing frame glasses;
- Use specially designed myopia control lenses such as hard contact lenses (including care products), multifocal contact lenses, progressive multifocal lenses, and atropine drugs within 1 month before screening or during the planned study period;
- Participating in other clinical trials within 3 months prior to screening;
- Those who cannot perform regular eye examination;
- Other investigators consider it inappropriate to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, District, Suzhou City, Jiangsu Province
Jingyan Yao, 13862578532, yaojingyan@suda.edu.cn
About this study
Official title: A Prospective, Single-center, Randomized, Double-blind, Controlled, Optimal Clinical Study to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
The objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents. A total of 156 subjects meeting the requirements of the study protocol were included. During the study, subjects were required to wear the test product (defocus lens A or defocus lens B) or the control product (aspheric lens) for 12 months, and regular follow-up was required during the wearing process, including various ophthalmological examinations and subjective feelings about wearing the lens. During the study period, the product status, ocular conditions, adverse events and serious adverse events were continuously observed to evaluate the safety and effectiveness of the test product in clinical use.
- Conditions
- Myopia
- Being tested
- Microstructure lens A, Microstructure lens B, Control group
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microstructure lens ADevice
Subjects randomized to Trial Group A will be required to wear microstructural lens A (microstructural design type with low defocus ratio) for 12 months
Microstructure lens BDevice
Subjects randomized to Trial B will be required to wear microstructural lens B (high defocus ratio microstructural design type) for 12 months
Control groupOther
Subjects randomized to the control group will be required to wear aspherical single-light lenses for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Trial Group A | Experimental | 12-month defocusing lens (microstructured lens A) Receives: Device: Microstructure lens A |
| Trial Group B | Experimental | 12-month defocusing lens (microstructured lens B) Receives: Device: Microstructure lens B |
| Control group | Active comparator | 12 months wearing aspherical lens Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change value of equivalent spherical lens after cycloplegia (subjective refraction)
Subjective optometry after ciliary paralysis was measured by blind researchers (who did not participate in the screening and treatment of subjects), and the final equivalent spherical degree was recorded, and the difference between the subjective optometric equivalent spherical results after ciliary paralysis in the baseline period (before wearing lenses) was recorded.
Measured: After 12 months of wearing glasses
Secondary outcomes (6)
Equivalent spherical lens strength after ciliary paralysis (subjective optometry)
The subjects were subjected to subjective refraction after ciliary paralysis by the investigator, and the corresponding value of equivalent spherical mirror was recorded.
Measured: Screening period and wearing glasses for 3 months, 6 months, 12 months
Axis length
The length of the eye axis was measured by the researcher and the corresponding value was recorded.
Measured: Screening period and wearing glasses for 3 months, 6 months, 12 months
Regulating sensitivity
The researchers conducted sensitivity adjustment tests on the subjects and recorded the test results.
Measured: Screening period and wearing glasses for 3 months, 6 months, 12 months
Stereopsis
The researchers tested the subjects' near-stereoscopic vision and recorded the test results.
Measured: Screening period and wearing glasses for 3 months, 6 months, 12 months
Corneal curvature
The subjects were examined for corneal curvature by the investigator and the results were recorded.
Measured: Screening period and wearing glasses for 3 months, 6 months, 12 months
Subjective perception rating for wearing a mirror
According to their subjective feelings, the subjects were evaluated by Visual Analogue Scales (VAS). The VAS score is on a 10cm scale marked with the words "0" and "10" at each end. "0" is comfortable, "10" is unbearable.
Measured: On the day of wearing the glasses and 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months after wearing the glasses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start7 Apr 2024
- Primary completion7 Nov 2025 (estimated)
- Study completion7 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Mingshi Optical Technology Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411717
- Sponsor's protocol ID
- MS-CTP
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized, Double-blind, Controlled, Optimal Clinical Study to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
- ClinicalTrials.gov ID
- NCT06411717
- Acronym / sponsor ID
- MS-CTP
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.University, hospital or other
- Collaborators
- Suzhou Mingshi Optical Technology Co., Ltd
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 7 Nov 2025 (estimated)
- Study completion
- 7 Mar 2026 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents. A total of 156 subjects meeting the requirements of the study protocol were included. During the study, subjects were required to wear the test product (defocus lens A or defocus lens B) or the control product (aspheric lens) for 12 months, and regular follow-up was required during the wearing process, including various ophthalmological examinations and subjective feelings about wearing the lens. During the study period, the product status, ocular conditions, adverse events and serious adverse events were continuously observed to evaluate the safety and effectiveness of the test product in clinical use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trial Group A | Experimental | Device: Microstructure lens A12-month defocusing lens (microstructured lens A) |
| Trial Group B | Experimental | Device: Microstructure lens B12-month defocusing lens (microstructured lens B) |
| Control group | Active comparator | Other: Control group12 months wearing aspherical lens |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 8~13 years old (including boundary values), gender is not limited;
- The spherical degree of subjective optometry in both eyes with cycloplegic muscle paralysis was between -1.00D and -6.00D (including the boundary value) (based on the mean value of subjective optometry), and the equivalent spherical difference of both eyes was less than 1.50D;
- Optimal corrected visual acuity ≥1.0 in left and right eye after ciliary muscle paralysis;
- In both eyes with cycloplegia, the degree of the column lens was ≤1.50 days;
- Voluntarily participate in the clinical study, sign the informed consent, and obtain the written consent of the guardian;
Key exclusion criteria (12 listed)
- Subjects who met any of the following criteria at the time of the screening visit were excluded from the study:
- Have a history of eye trauma or intraocular surgery;
- Abnormal results of slit-lamp examination (see Annex 1 for details);
- fundus examination results ≥ grade 2 (see Annex 1 for details);
- Intraocular pressure < 10mmHg or > 21mmHg or intraocular pressure difference ≥5mmHg;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microstructure lens ASubjects randomized to Trial Group A will be required to wear microstructural lens A (microstructural design type with low defocus ratio) for 12 months | Device | Trial Group A |
| Microstructure lens BSubjects randomized to Trial B will be required to wear microstructural lens B (high defocus ratio microstructural design type) for 12 months | Device | Trial Group B |
| Control groupSubjects randomized to the control group will be required to wear aspherical single-light lenses for 12 months | Other | Control group |
Primary outcome
Change value of equivalent spherical lens after cycloplegia (subjective refraction)
Time frame: After 12 months of wearing glasses
Subjective optometry after ciliary paralysis was measured by blind researchers (who did not participate in the screening and treatment of subjects), and the final equivalent spherical degree was recorded, and the difference between the subjective optometric equivalent spherical results after ciliary paralysis in the baseline period (before wearing lenses) was recorded.
6 secondary outcomes
Equivalent spherical lens strength after ciliary paralysis (subjective optometry)
Time frame: Screening period and wearing glasses for 3 months, 6 months, 12 months
Axis length
Time frame: Screening period and wearing glasses for 3 months, 6 months, 12 months
Regulating sensitivity
Time frame: Screening period and wearing glasses for 3 months, 6 months, 12 months
Stereopsis
Time frame: Screening period and wearing glasses for 3 months, 6 months, 12 months
Corneal curvature
Time frame: Screening period and wearing glasses for 3 months, 6 months, 12 months
Subjective perception rating for wearing a mirror
Time frame: On the day of wearing the glasses and 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months after wearing the glasses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microstructure lens A and Microstructure lens B in people with Myopia, run by Suzhou Care-Real Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingyan Yao (＋86 13862578532, yaojingyan@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change value of equivalent spherical lens after cycloplegia (subjective refraction) (time frame: After 12 months of wearing glasses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.